Anti-rheumatic Drug Use and Risk of COVID-19 Infection in... | NCT04434118

Studies
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients

NCT04434118

Sponsor

Sadat City University

Status

Withdrawn

Last Update Posted

May 9, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis
COVID

Interventions

Traditional antirheumatic drugs

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Institutional Issue

Expanded Access Info

Start Date

Mar 20, 2020Actual

Primary Completion Date

Dec 30, 2021Actual

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Jun 13, 2020

First Submission Date that Met QC Criteria

Jun 15, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2022

Last Update Posted Date

May 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, PhD., Sadat City UniversityPrincipal Investigator

Lead Sponsor

Sadat City UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rheumatoid Arthritis with COVID-19			Drug: Traditional antirheumatic drugs
Rheumatoid Arthritis without COVID-19			Drug: Traditional antirheumatic drugs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Traditional antirheumatic drugs	Drug	Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine	Rheumatoid Arthritis with COVID-19 Rheumatoid Arthritis without COVID-19

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The risk of COVID-19 infection among RA patients	Realtion between hydroxychloroquine use and COVID-19 infection	12 week

Secondary Outcomes

Measure	Description	Time Frame
The incidence of hospitalization for Covid-19 patients.	Number of cases and number of hospitalization days	12 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.

Exclusion Criteria:

The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients fulfilling 2010 ACR-EULAR classification criteria for RA

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Shibīn al Kawm			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided